MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	1555200500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.X-ray review results: post-op x-rays for thoraco-lumbar fusion show rods out of the screw heads at the sacral/il screws.The patient has an flat back and flat sacral slope and it does not appear that lordosis on connection of the saggital deformity was achieved with the initial surgery.By report fusion had not occurred at the lumbo sacral junction.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient underwent posterior spine fusion surgery at t11-pelvis.Post-op, the implanted rod broke.Solid fusion fused in some areas but not the lumbosacral junction.The patient suffered with pain as a result of this event.Patient underwent revision surgery as a result of this event where the device has been removed from the patient body.
Additional Manufacturer Narrative
Product analysis results: visual and microscopic inspection confirmed the rod has been bent and broke.Multiple witness marks across the surface of the rod consistent with the break off screw interface when seated in the saddle of the screw head.Microscopic inspection of the fracture surfaces confirmed a fairly flat fracture surface with gently convex progressive striations through the cross-sectional area of the rod, which are indicative of cyclic fatigue.Dimensional inspection rod diameter confirms conformance to print specification.After visual, microscopic and dimensional inspection, no evidence was found that would suggest a defect in manufacturing or processing of the implant.The above observations are consistent with cyclic fatigue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 8849552
• Report Number: 1030489-2019-00845
• Device Sequence Number: 1400956
• Product Code: NKB
• UDI-Device Identifier: 00643169272255
• UDI-Public: 00643169272255
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K131321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1555200500
• Device Lot Number: 0623730W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 09/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 47 YR